K-number	K780320
Device name	PASSIVE TENDON IMPLANT
Applicant	Holter-Hausner Intl.
Product code	HXA
Device class	Class II
Decision date	Mar 17, 1978
Decision	Substantially Equivalent
Regulation	888.3025

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View the full FDA submission: accessdata.fda.gov

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PASSIVE TENDON IMPLANT

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